FDA.reportPublic FDA data

Banana Boat

Product NDC
63354-481
11-digit product format
633540481
Labeler code
63354
Product ID
63354-481_27c51ad3-5f8e-032d-e063-6394a90a4860
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
Edgewell Personal Care Brands, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-05-30
Substance
OCTISALATE; AVOBENZONE; HOMOSALATE; OCTOCRYLENE
Active strength
4; 3; 9; 5 g/100g; g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63354-48163354-481-21DDiscontinued by firm2026-10-28

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Banana Boat
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE4 g/100g
AVOBENZONE3 g/100g
HOMOSALATE9 g/100g
OCTOCRYLENE5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8a1eefa6-619e-5d02-e053-2995a90a3d75Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-481-21Banana Boat29 g in 1 TUBELOTION296
63354-481-24Banana Boat177 g in 1 TUBELOTION1776
63354-481-27Banana Boat270 g in 1 TUBELOTION2706

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-481BANANA BOAT (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [EDGEWELL PERSONAL CARE BRANDS, LLC]6Current NDC, Legacy NDC, 3 package rows20241127_8a1eefa6-619e-5d02-e053-2995a90a3d75.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 202 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KARA VITA Moisturizing Sunscreen with DNArescueOXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATEKara Vita, Inc.2130e9ac-5946-4b00-94d0-a78fd1ccfd132025-07-25WarningsExact identifier
application number: M020
78 x 36 SPF 30 ActiveZINC OXIDEDermazone LLC96a8aacc-5c2f-410a-8fb4-8b3bc0f81e552025-07-25WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 01N LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L2ccf4e45-4cec-417d-9f4c-28f376025f1d2025-07-25WarningsExact identifier
application number: M020
celazome Moisturizing SPF 30 ActiveOXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATEDermazone LLC5ec1510d-1465-4849-9e23-f16e11ff0e652025-07-25WarningsExact identifier
application number: M020
Skinuva Scar plusZINC OXIDEMD Medical Designs, Inc.5fcad8c3-a268-4966-b0a9-6cd2c7afd3b72025-07-25WarningsExact identifier
application number: M020
celazome Moisturizing SPF 29 Active with DNArescueOXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATEDermazone LLC99fb90ca-6527-459b-8af2-627ea9abe11b2025-07-25WarningsExact identifier
application number: M020
The Men Pen TALLOW GUARD SPF 30 PREMIUM ZINC SUNSCREENZINC OXIDEGuangzhou Haishi Biological Technology Co., Ltd.3aa93f52-ec01-01c2-e063-6294a90a93472025-07-24WarningsExact identifier
application number: M020
Mineral Suscreen SPF 30ZINC OXIDE 19.0%Vivant Pharmaceuticals, LLC3aadb658-d12d-ae8d-e063-6394a90a64962025-07-24WarningsExact identifier
application number: M020
SunscreenTITANIUM DIOXIDE 6.8%Baxter of California, LLC146030bc-2bf4-25ea-e063-6294a90a46132025-07-24WarningsExact identifier
application number: M020
Leg and Body Makeup Broad Spectrum SPF 25OCTISALATE 3.2% OCTOCRYLENE 6%Baxter of California, LLC14adc826-6e9d-382a-e063-6294a90a5d792025-07-24WarningsExact identifier
application number: M020
Tiege Hanley AM Morning Facial Moisturizer with SPF 20AVOBENZENE, OCTINOXATE, OCTOCRYLENETIEGE HANLEY, Inc22086cd8-2126-120e-e063-6394a90a561e2025-07-24WarningsExact identifier
application number: M020
Tulip Dew SHIELD GLOWZINC OXIDEBloomeffects, Inc.150f9660-48ec-a189-e063-6294a90a6d492025-07-23WarningsExact identifier
application number: M020
Pelotan Sunscreen Broad Spectrum SPF 30AVOBENZONE, OCTINOXATE, OCTOCRYLENEPelotan LLC3a9f94eb-98b7-5a20-e063-6394a90a173b2025-07-23WarningsExact identifier
application number: M020
Basin Frosted Orange Cream SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a9fc050-f74f-a431-e063-6294a90ad4c22025-07-23WarningsExact identifier
application number: M020
Pelotan Sunscreen Broad Spectrum SPF 30AVOBENZONE, OCTINOXATE, OCTOCRYLENEPelotan LLC3aa0799b-0790-2476-e063-6294a90a8bcc2025-07-23WarningsExact identifier
application number: M020
The Men Pen TALLOW GUARD SPF 30 PREMIUM ZINC SUNSCREENZINC OXIDEGuangzhou Haishi Biological Technology Co., Ltd.3aa3c442-26a6-0ab0-e063-6294a90a93a52025-07-23WarningsExact identifier
application number: M020
Basin Italian Gelato SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a89106d-dbf0-e6ea-e063-6294a90a60f32025-07-22WarningsExact identifier
application number: M020
Basin American Mint Julep SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a898964-b4aa-e86d-e063-6394a90a34c62025-07-22WarningsExact identifier
application number: M020
No7 Future Renew Damage Reversal System KitAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS3512c120-b8ba-ba59-e063-6394a90ac1e22025-07-22WarningsExact identifier
application number: M020
Basin Lime Sugar SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a89d736-efef-088e-e063-6394a90a5e622025-07-22WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63354-481-216335404812129 g in 1 TUBE (63354-481-21) 29 g2019-05-300000-00-00NoNoCurrent
63354-481-2463354048124177 g in 1 TUBE (63354-481-24) 177 g2019-05-300000-00-00NoNoCurrent
63354-481-2763354048127270 g in 1 TUBE (63354-481-27) 270 g2019-08-082026-12-01NoNoCurrent